Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy - Full Text View

Sponsor:	Institute of Cardiology, Warsaw, Poland
Information provided by:	Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:	NCT00821353

Purpose

Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients with hypertrophic cardiomyopathy (HCM) and represents an important complication in the clinical course of the disease, with adverse long-term consequences on functional status and outcome.

Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is challenging because of the limited long-term efficacy and potentially hazardous side effects of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is successfully used in clinical practice. However, comparison of the efficacy and safety of these two therapeutic options has not been done up till now in randomized manner in this group of patients.

Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs. antiarrhythmic drug therapy in patients with HCM and AF.

Condition	Intervention	Phase
Atrial Fibrillation Hypertrophic Cardiomyopathy	Procedure: RF catheter ablation Drug: Antiarrhythmic drugs	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Cardiomyopathy

U.S. FDA Resources

Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:

Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in total symptomatic and asymptomatic AF burden. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Incidence of complications. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Changes in left atrial diameter and left ventricular function. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes in level of Nt-pro-BNP. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes in symptom severity and quality of life. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes in exercise capacity assessed by cardiopulmonary exercise testing. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
RFCA: Active Comparator	Procedure: RF catheter ablation RF catheter ablation
Drug: Active Comparator	Drug: Antiarrhythmic drugs One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with hypertrophic cardiomyopathy and paroxysmal or chronic atrial fibrillation

Exclusion Criteria:

Severe hear failure (NYHA IV)
Left ventricular ejection fraction <0.30
Left atrial diameter >65 mm
Age > 70 years
Contraindication to anticoagulation with warfarin
Presence of a mechanical prosthetic valve
Presence of left atrial thrombus on TEE or CT
Woman currently pregnant
Renal failure (GFR < 30 ml/min)
Hepatic failure
Untreated hypothyroidism or hyperthyroidism
LVOT gradient > 50 mmHg

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821353

Contacts

Contact: Pawel Derejko, MD, PhD	+48 22 3434 326	pderejko@yahoo.com
Contact: Lidia Chojnowska, MD, PhD	+48 22 3434 340	lchojnowska@ikard.pl

Locations

Poland
Institute of Cardiology	Recruiting
Warsaw, Poland
Contact: Pawel Derejko, MD, PhD + 48 603 33 88 71 pderejko@yahoo.com
Principal Investigator: Pawel Derejko, MD, PhD

Sponsors and Collaborators

Institute of Cardiology, Warsaw, Poland

Investigators

Principal Investigator:	Pawel Derejko, MD, PhD	Institute of Cardiology, Warsaw, Poland
Principal Investigator:	Lidia Chojnowska, MD, PhD	Institute of Cardiology, Warsaw, Poland
Principal Investigator:	Lukasz Szumowski, MD, PhD	Institute of Cardiology, Warsaw, Poland
Principal Investigator:	Franciszek Walczak, MD, PhD	Institute of Cardiology, Warsaw, Poland

More Information

No publications provided

Responsible Party:	Institute of Cardiology, Warsaw, Poland ( Pawel Derejko M.D. Ph.D. )
Study ID Numbers:	N N402 194635, 1.7/IV/08
Study First Received:	January 11, 2009
Last Updated:	September 30, 2009
ClinicalTrials.gov Identifier:	NCT00821353 History of Changes
Health Authority:	Poland: Ministry of Health

Keywords provided by Institute of Cardiology, Warsaw, Poland:

Atrial fibrillation
Hypertrophic cardiomyopathy
RF ablation
Antiarrhythmic drugs

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Agents
Cardiomyopathies
Pharmacologic Actions
Heart Valve Diseases
Hypertrophy
Pathologic Processes

Aortic Stenosis, Subvalvular
Therapeutic Uses
Cardiomyopathy, Hypertrophic
Cardiovascular Diseases
Atrial Fibrillation
Anti-Arrhythmia Agents
Aortic Valve Stenosis
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010